Clomiphene Citrate for Treatment of Acromegaly

Phase 2

Completed

• Conditions: Acromegaly
• Interventions: Drug: Clomiphene Citrate

• Registration Number: NCT02274311
• Lead Sponsor: Felipe Henning Gaia Duarte

Brief Summary

To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone receptor antagonist)

Detailed Description

Acromegaly, a disease caused by a growth hormone secreting pituitary adenoma, results in reduced life span. Despite the many modalities available to treat this disease,as surgery, medical treatment and radiotherapy, uncontrolled disease persists in a significant portion of patients

Oral estrogens, alone or in combination with somatostatin receptor analogues, have been shown to control acromegaly in women. Selective estrogen receptor modulators (SERMs) resulted in similar effects in both genders. Clomiphene citrate, a SERM that increases luteinizing hormone and follicle stimulating hormone secretion, improves hypogonadism and fertility outcomes.

The aim of this study is to assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatment.

In this prospective, open label, single center trial, sixteen male patients were studied. Clomiphene citrate (50 mg/day) was added to previous medical treatment for 3 months and hormonal assessment was performed prior to and during the intervention. Hormones included: growth hormone, insulin like growth factor, total testosterone, follicle stimulating hormone, luteinizing hormone and prostate-specific antigen.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-24
• Results First Submitted: 2015-12-01
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-15
• Results First Posted: 2019-05-07
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• patients with active acromegaly on regular use of a stable dose of Octreotide-LAR and/or cabergoline for at least one year,
• Insulin like growth factor 1 above the reference range during the last year of follow-up and
• testosterone levels within or below the third inferior tertile of normality.

Exclusion Criteria

• radiotherapy in the last 10 years, previous venous embolism (including family members),
• previous prostatic cancer or symptomatic benign hypertrophy,
• triglyceride levels above 400 mg/dL,
• renal failure defined by estimative of renal filtration below 30 ml/min,
• liver disease defined by hepatic enzymes 3 times above normal limit,
• active oncologic disease in the last 10 years and previous cardiac or cerebrovascular disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clomiphene citrate	Clomiphene Citrate	Patients receiving clomiphene citrate

Primary Outcome Measures

Name	Time	Method
IGF-1 Levels	Day 90	The objective is to compare the change of IGF-1 value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).

Secondary Outcome Measures

Name	Time	Method
Testosterone Levels	D90	The objective is to compare the change of testosterone value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).
PSA Levels	Day 90	The objective is to compare the change of PSA value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).